MAY 2004

WEEK ENDING MAY 1

PRODUCT DURAGESIC 75 ug/h CII (FENTANYL TRANSDERMAL SYSTEM), 75 ug/h fentanyl and 0.3 mL alcohol USP, 75 mcg patches, Rx only.
CODE Lot Numbers: 0327192, 0327193, 0327294, 0327295, and 0330362.
RECALLING FIRM/MANUFACTURER Recalling Firm: Janssen Pharmaceutica Products, L.P., Titusville, NJ.
Manufactured by: Alza Corporation, Mountain View, CA.
REASON Defective Container: Due to a seal breach on one edge of the system, product has the potential to release higher or too little medication than intended amount.
VOLUME OF PRODUCT IN COMMERCE 438,888 patches/2,043,364 patches.
DISTRIBUTION Nationwide.

WEEK ENDING MAY 8

PRODUCT Doxazosin Mesylate Tablets, 1mg, 100 count bottles.
CODE Lot Number/Expiration Date: Lot 107678A (June, 2004).
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami, FL.
REASON Dissolution Failure: 18 month timepoint (stability).
VOLUME OF PRODUCT IN COMMERCE 7,008 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Senokot Granules (standardized senna concentrate), Natural Vegetable Laxative, 2 oz and 12 oz, 15mg
sennosides per teaspoon
b) Senokot Tablets (standardized senna concentrate), 8.6 mg sennosides, Natural Vegetable Laxative, 100 count
bottles.

c) Senokot Syrup (extract of senna concentrate), Sennosides 8.8mg, Natural Vegetable Laxative, 8 Fl oz., Alcohol-Free Formula.
d) Senokot Children's Syrup, (extract of senna concentrate), 8.8 sennosides, 2.5 Fl. Oz. Alcohol Free.
e) X-Prep Bowel Evacuant Liquid, extract of senna concentrate, 130 mg sennosides, 2.5 Fl oz.
f) X-Prep Bowel Evacuant Kit-1, Extract of Senna concentrate, 130 mg sennosides, Bisacodyl 10 mg,
Docusate sodium 50mg, 2.5 Fl oz. Contents: X-Prep Liquid 2 1/2 Fl. oz, Alcohol-Free Formula, 2 Senokot-S Tablets, 1 Rectolax suppository.
CODE
a) Lot GT52 exp. 2/28/2007 Lot 69G1 exp. 2/28/2004;
b) Lot DC11 exp. 5/31/2006 Lot FF51 exp. 9/30/2006;
c) Lot RB01 exp. 10/31/2004;
d) Lot PS61 exp. 8/31/2004; Lot PS71 exp. 8/31/2004; Lot RB21 exp. 10/31/2004; Lot RM21 exp. 11/30/2004;
e) Lot KV71 exp. 3/31/2004; Lot MD12 exp. 5/31/2004;
f) Lot PM39 exp. 5/31/2004; Lot MY59 exp. 5/31/2004.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON Superpotent: Out of specification results obtained during retesting.
VOLUME OF PRODUCT IN COMMERCE 331,885 units.
DISTRIBUTION Nationwide.

WEEK ENDING MAY 15

FDA Announces Recall of "DU" Brand Nasal Decongestant Due To Possible Health Risk

FDA today alerted consumers not to purchase or use a recalled lot of DU brand nasal decongestant spray (distributed by Drugs Unlimited, of Puerto Rico) because it may be contaminated with Burkholderia cepacia – a bacterium that could cause serious, potentially life-threatening infections in some patients. Individuals with compromised immune systems, especially those with cystic fibrosis, could be at risk.

The recalled product is sold over the counter in 15 milliliter (or “1/2 ounce”) and 30 milliliter bottles labeled “DU 12-Hour Nasal Spray” with the lot number J4492 imprinted at the bottom of the carton and the back of the bottle label. The recalled product also bears an expiration date of 9/06.

The product appears to have been distributed throughout Puerto Rico and it is likely linked to an earlier recall of other contaminated product lots that were sold to other distributors.

Consumers who have used the recalled product may want to consult their physicians. Consumers who may still have the recalled product should not use it, but instead return it immediately to the stores where it was purchased. Wholesalers and retailers who purchased the product should return it to the appropriate distribution center. Anyone needing more information can call Rey Farinas at 305-592- 9216.

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Consumer Alert of Children's Motrin Grape Chewable Tablets

McNeil Consumer & Specialty Pharmaceuticals is alerting consumers that one manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin (ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol 8-Hour® extended release (acetaminophen) Geltabs. Lot # JAM108 was distributed nationwide to wholesale and retail customers between February 5 and April 1, 2004. The bottles are labeled as containing 24 tablets.

The Tylenol 8-Hour product provides an adult dose of acetaminophen, and use of this adult product could provide more than the recommended dose (overdose) for children. The mislabeled bottles appear to be the result of a packaging error for this one lot.

The two medicines are visibly different. Children's Motrin Grape Chewable Tablets are round, purple-colored, scored tablets with the letters MO and the number 50 on the tablet surface. These tablets have a non-glossy finish and a grape smell. The Tylenol 8-Hour Geltabs are hard, round, gelatin coated and shiny. The geltabs are white on one side, red on the other, with "8 Hour" printed in blue on either the red or the white side.

Consumers can identify the manufacturing lot number that is embossed on the carton end flap, and printed on the bottle label under McNeil's address as "Exp 1/06 JAM108".

Anyone identifying one of the bottles included in this consumer alert should contact McNeil's Consumer Relationship Center at 1-800-962-5357.

Parents who believe their children may have taken Tylenol 8-Hour Geltabs, believing them to be Children's Motrin Grape Chewable Tablets, should contact their health care provider or a poison control center immediately

For more information on this consumer alert, or to report an adverse event, please call McNeil's Consumer Relationship Center at 1-800-962-5357.

PRODUCT
a) SOTATOL HCl TABLETS (sotalol hydrochloride),120 mg, 100 TABLETS, Rx only, Distributed under the Par label. NDC 49884-583-01.
b) ACYCLOVIR TABLETS, 400 mg, Rx only, 100 TABLETS, NDC 49884-566-01.
CODE
a) Lot Numbers/Expiration Dates: DL151, expiration date: MAY 2005; DL521, expiration date: MAY 2005; DL531, expiration date: MAY 2005; DN921, expiration date: JULY 2005; DN931, expiration date: JULY 2005; DN941, expiration date: JULY 2005; DS561, expiration date: JULY 2005; DS571, expiration date: JULY 2005;
b) Lot Numbers/Expiration Dates: DL151, expiration date: MAY 2005; DL521, expiration date: MAY 2005; DL531, expiration date: MAY 2005; DN921, expiration date: JULY 2005; DN931, expiration date: JULY 2005; DN941, expiration date: JULY 2005; DS571, expiration date: JULY 2005 , DS561, expiration date. July 2005.
RECALLING FIRM/MANUFACTURER Par Pharmaceutical , Spring Valley , NY.
REASON Mislabeling: some bottles of "ACYCLOVIR TABLETS 400 mg" were affixed with an additional outer label (outsert) over the base label incorrectly identifying the product as "SOTALOL HCL TABLETS, 120 mg".
VOLUME OF PRODUCT IN COMMERCE 30,523 bottles of 100 tablets.
DISTRIBUTION Nationwide.

PRODUCT Z-Cof DM Liquid, Each 5mL/one teaspoon contains: Dextromethorphan HBr 15mg, Pseudoephedrine HCl 32mg, and Guaifenesin 200mg, 16 fl oz (473)mL bottles , Alcohol free, No antihistamine, Grape Flavor, Rx Only. NDC 65224-619-16.
CODE Lot number 40318.
RECALLING FIRM/MANUFACTURER Elge, Inc, Rosenberg , TX.
REASON Misprint in package insert; insert indicates dosage administration as Adults and children 2 years of age and older rather than Adults and children 12 years of age and older.
VOLUME OF PRODUCT IN COMMERCE 6,139 pints .
DISTRIBUTION Nationwide.

PRODUCT Nubain Injection (Nalbuphine Hydrochloride), 10 mg per mL injection, 10 mL Multiple Dose Vial, For Intramuscular, Subcutaneous or Intravenous Use, Rx Only. NDC 63481-508-05.
CODE MPK585A1, exp. date 8/31/04 .
RECALLING FIRM/MANUFACTURER Endo Pharmaceuticals Inc., Chadds Ford , PA.
REASON Product contains metal particles.
VOLUME OF PRODUCT IN COMMERCE 31,298 vials.
DISTRIBUTION Nationwide.

PRODUCT BiCNU (carmustine for injection): Formerly known as (sterile carmustine [BCNU]), 100 mg and Diluent, Rx only. NDC 0015-3012-38.
CODE Lot LCE16; Exp. FEB 2005.
RECALLING FIRM/MANUFACTURER Bristol Myers Squibb Co. C.P.O., Mount Vernon , IN.
REASON Short fill; vial did not meet net content specifications.
VOLUME OF PRODUCT IN COMMERCE 29,803 vials.
DISTRIBUTION Nationwide, and International.

PRODUCT Wellskin Facial Cream, (octinoxate 5%; avobenzone 2%), SPF 15, 14% Glycolic Complex. NDC 64760-008-01.
CODE Lot Number: 119304.
RECALLING FIRM/MANUFACTURER Genesis Pharmaceutical, Inc., Hazel Park , MI.
REASON Mislabeling: The jars of labeled sunscreen were mispackaged with nightcream which product has no sunscreen properties.
VOLUME OF PRODUCT IN COMMERCE 233.
DISTRIBUTION Nationwide and Canada .

PRODUCT Lorazepam Tablets, USP, 0.5 mg, 60 count, 100 count and 500 count bottles, Rx only.

CODE Lot number/Expiration Date: Lot 47500 exp. 6/04.
RECALLING FIRM/MANUFACTURER Mutual Pharmaceutical Co., Inc., Philadelphia , PA.
REASON Stability Failure: 18 month CRT stability time period.
VOLUME OF PRODUCT IN COMMERCE 851,900 tablets.
DISTRIBUTION Nationwide.

PRODUCT Altace (Ramipril) Capsules, 1.25 mg, unit dose pack (10s/10 to a box - 100 units), Rx only. NDC 61570-110-56.
CODE Lot Number/Expiration Date: Lot No. 1053616, expiration 08/2004.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals Inc, Bristol , TN.
REASON Mislabeling: Product dosage labeling missing on a unit dose package.
VOLUME OF PRODUCT IN COMMERCE 2,696 units.
DISTRIBUTION Nationwide.

PRODUCT Acyclovir Tablets, USP, 800 mg tablets, 100 count bottles. NDC 0172-4268-60.

CODE Lot numbers/Expiration Dates: 116009A (03/2005) and 113874A (03/2005).
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami , FL.
REASON Tablets crumbling.
VOLUME OF PRODUCT IN COMMERCE 5,906 bottles.
DISTRIBUTION Nationwide.

PRODUCT AVONEX Injection (Interferon beta-1a), 30 mcg/0.5mL Prefilled Syringe, in administration dose packs of 1 and 4, RX only, For IM Injection Once-A-Week, Sterile. NDC 59627-002-06.
CODE Lot Numbers / Expiration Date: P30027 June 2005 , P30028 June 2005 , P30029 June 2005 , P30030 June 2005 , P30031 June 2005 , P30032 June 2005 , P30033 July 2005 , P30034 July 2005 , P30036 July 2005 , P30038 July 2005, P30039 August 2005.
RECALLING FIRM/MANUFACTURER Biogen Idec MA Inc., Cambridge , MA.
REASON Syringes exceed the specification for aggregrates.
VOLUME OF PRODUCT IN COMMERCE 32,784 (4 packs).
DISTRIBUTION Nationwide.

PRODUCT Nystatin Oral Suspension USP, 100,000 Units/mL, packaged in 60 ml bottles (NDC # 0472-1320-02) and 16 ounce bottles (NDC #0472-1320-16). Rx only.
CODE Lot Numbers/Expiration Dates: QH3260 (60 mL) EXP 09/05, QH3260 (16 oz.) EXP 03/05, QH3259 (16 oz.) EXP 03/05.
RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore , MD.

REASON Superpotent.
VOLUME OF PRODUCT IN COMMERCE 217,998 units.
DISTRIBUTION Nationwide.

PRODUCT PREMARIN (conjugated estrogens tablets USP), 0.625 mg, 5,000 count bottles, Rx.

NDC #0046-0867-95.
CODE Lot Number/Expiration Date: A15477, Exp. 09/04.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond , VA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 3,491 bottles.
DISTRIBUTION Nationwide.

FDA Announces Recall of "DU" Brand Nasal Decongestant Due To Possible Health Risk

The product appears to have been distributed throughout Puerto Rico and it is likely linked to an earlier recall of other contaminated product lots that were sold to other distributors.

WEEK ENDING MAY 22

PRODUCT Zyprexa (Olanzapine) tablets, 20 mg, 60 count bottle, Rx only. NDC 0002-4420-60.
CODE Lot numbers/Expiration Dates: 7ED11A Exp: 05/05; 7ED80A Exp: 06/05; 7EE34A Exp: 07/05; 7EE35A Exp. 07/05; 7ED85A Exp: 07/05; 7ED86A Exp: 07/05; 7ED87A Exp: 07/05; 7EJ26A Exp: 07/05; 7EJ28A Exp: 11/05; 7EJ29A Exp: 11/05; 7EJ31A Exp: 11/05; 7EJ32A Exp: 11/05; 7EJ33A Exp: 11/05.
RECALLING FIRM/MANUFACTURER TXRX, Humble, TX.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 63 bottles.
DISTRIBUTION Nationwide.

PRODUCT Ibuprofen Tablets USP, 200 mg, 50 tablets and 100 coated Tablets. Also sold under brands: Medic Ibuprofen tablets and Family Dollar Savings Ibuprofen I-B.
CODE Lot Number/Expiration Date: Lot A475905, Exp. Date 12/2005.
RECALLING FIRM/MANUFACTURER Pharmaceutical Formulations Inc., Edison, NJ.
REASON Adulterated Presence of Foreign Tablets.
VOLUME OF PRODUCT IN COMMERCE 3,597,253.
DISTRIBUTION Nationwide.

PRODUCT Premarin (conjugated estrogens tablets USP), 1.25 mg, 1000 count bottles, Rx only. NDC 0046-0866-91.

CODE A44299 Exp. 12/2005.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure; 9 month stability.
VOLUME OF PRODUCT IN COMMERCE 9,217 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Microgestin Fe 1.5/30, (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate
tablets), 28-Day Regimen, Each green tablet (21) contains 1.5 mg norethindrone acetate and 30 mcg ethinyl
estradiol, each brown tablet (7) contains 75 mg ferrous fumarate, 6 Tablet Dispensers, 28 tablets each, Rx only,
NDC 52544-631-28.
b) Microgestin Fe 1/20, (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets),
28-Day Regimen, Each white tablet (21) contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, each
brown tablet (7) contains 75 mg ferrous fumarate, 6 Tablet Dispensers, 28 tablets each, Rx only. NDC 52544-
630-28.
CODE
a) Lot 63103H03, Exp. Date July 2005;
b) Lot 63003M03, Exp. Date July 2005.
RECALLING FIRM/MANUFACTURER Watson Pharmaceuticals, Inc., Corona, CA.
REASON Defective container; film/foil separation of blister packaging.
VOLUME OF PRODUCT IN COMMERCE 33,374 cartons.
DISTRIBUTION Nationwide.

PRODUCT Clear brand Lice Egg Remover (Stainless Steal Comb and Activated Enzyme Mousse) 2 Fl. Oz. (59.1 ml) pump dispenser.
CODE Lot Number/Expiration Date: Lot CM1001, 04/2007.
RECALLING FIRM/MANUFACTURER International Chemical, Inc., Amherst, NY.
REASON Mislabeling: Dispensing container of Lice Egg Remover Mousse was inadvertently labeled as Lice Killing Shampoo.
VOLUME OF PRODUCT IN COMMERCE 3,216 units (268 cases of 12).
DISTRIBUTION Nationwide.

WEEK ENDING MAY 29

PRODUCT MINI EPHEDRINE Tablets, Bronchodilator and Expectorant, Each tablet contains 12.5 mg Ephedrine HCl, 200 mg Guaifenesin, 6 tablets per packet, Over-the-Counter.
CODE 3L001, Exp. 11/05.
RECALLING FIRM/MANUFACTURER Ultra-Seal Corporation, New Paltz, NY.
REASON Mispacked: 25 mg ephedrine HC1/200 mg guaifenesin tablets were repacked into packets labeled as containing 12.5 mg ephedrine HC1/200 mg guaifenesin tablets.
VOLUME OF PRODUCT IN COMMERCE 308,832 packets.
DISTRIBUTION Nationwide.

PRODUCT VisiClear Sterile Eye Drops (methyl cellulose 0.3% and glycerin 1.3%), 2 ml tubes, packaged in 4 count boxes, over-the-counter, NDC# 65650-017-09.
CODE 3081902/30600.
RECALLING FIRM/MANUFACTURER Tri Medica, Inc., Tempe, AZ.
REASON Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE 23,569 ampules.
DISTRIBUTION Nationwide, Barbados, and Great Britain.

PRODUCT OxyContin" 20 mg (oxycodone HCL, controlled release) Tablets, 100 count bottles, Rx Only. NDC 59011-103-10.
CODE Lot No. WS031, Expiration date: 09/30/06.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON Tablet mixup; bottle labeled as OxyContin" 20 mg tablets contained OxyContin" 20 mg tablets and one OxyContin" 10 mg tablet.
VOLUME OF PRODUCT IN COMMERCE 15,428/100 count bottles.
DISTRIBUTION Nationwide.

PRODUCT Premarin (conjugated estrogens tablets, USP), 0.625 mg, 100 and 1000 count bottles, Rx only. NDC 0046-0867-91 (1000s), NDC 0046-0867-81 (100s).

CODE Lot Numbers: 021372A (1000s); 021372B and 021372C (100s). Exp. Date: SEP 30 04.
RECALLING FIRM/MANUFACTURER Amerisource Health Services Corp, Columbus, OH.
REASON Failure to meet USP dissolution specifications by manufacturer.
VOLUME OF PRODUCT IN COMMERCE 23,039 bottles.
DISTRIBUTION Nationwide.